BioTechLogic Lithuania

独立来源是否相符？

关于

立陶宛拥有世界一流的激光和光子公司集群。受益于维尔纽斯大学的物理传统，BioTechLogic 立陶宛生产医疗设备、激光系统和精密光学仪器。该公司向欧洲、美国和日本出口激光和医疗技术产品。

品类

医疗保健用品电力及电力设备

主要市场

🇩🇪 德国 🇺🇸 美国 🇬🇧 英国 🇯🇵 日本 🇫🇷 法国

认证（已声明）

CE Marking

探索

立陶宛 的分销商立陶宛 的 医疗保健用品立陶宛 的 电力及电力设备

适用于这些商品的规则

本行业货运通常适用的法规。并非法律意见：请以链接的官方来源为准。

• Medical devices sold in the EU must carry CE marking under the Medical Device Regulation (EU) 2017/745, with a conformity assessment matched to the device risk class. European Commission (MDR)
• For the US market, the maker must have an FDA device establishment registration and product listing; most instruments also need 510(k) premarket clearance. US FDA (devices)
• Electronics for the EU need CE marking incl. RoHS substance limits, and producers must register for WEEE take-back in each member state of sale. European Commission (CE)
• Electronics for the US market need FCC equipment authorization under 47 CFR Part 15, which covers unintentional radiators such as switch-mode power supplies, not only radio devices. US FCC (Part 15)